Clinical trials in degenerative diseases最新文献

{"title":"Efficacy and safety of Mamajjaka Ghanavati in the treatment of type-2 diabetes mellitus: a prospective open label multi-center clinical study","authors":"M. Shubhashree, Bikartan Das, G. C. Nanda, G. Swamy, S. Ota, S. Doddamani, M. Rao, V. Tewari, B. Sharma, S. Khanduri, Rakesh Rana, R. Singhal, Adarsh M. Kumar, Narayanam Srikanth","doi":"10.4103/2542-3975.254106","DOIUrl":"https://doi.org/10.4103/2542-3975.254106","url":null,"abstract":"Background and objectives: The purpose of this study is to investigate the efficacy and safety of Mamajjaka Ghanavati on blood glucose level, symptoms, and quality of life in patients with type 2 diabetes mellitus. Subjects and methods: This prospective, multi-center, open-label, single-arm clinical study was performed at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, New Delhi during April 2016 to May 2017. A total of 177 eligible patients with type 2 diabetes mellitus were included and administered Mamajjaka Ghanavati two tablets (500 mg each) twice daily after food for 84 days. At the end of the treatment period (84th day), the changes in Diabetes Symptom Questionnaire (i.e., glycosylated hemoglobin and fasting and postprandial blood sugar levels) were analyzed. Quality of life was evaluated using 36-Item Short Form Health Survey (SF-36). Clinical safety of Mamajjaka Ghanavati was assessed by liver and renal function tests. This study was approved by the Medical Ethics Committee of Central Council for Research in Ayurvedic Sciences, New Delhi (approval number: CTRI Reg No Ref/2016/06/011468) on March 14, 2016. Results: Compared to baseline data, after 84 days of treatment with Mamajjaka Ghanavati, Diabetes Symptom Questionnaire score was significantly decreased, and SF-36 score was significantly increased (both P Conclusion: Mamajjaka Ghanavati can greatly improve the quality of life and is safe in the treatment of type 2 diabetes mellitus. Actually, Mamajjaka Ghanavati does not change blood sugar level greatly. Trial registration: This study was registered in the Clinical Trial Registry of India (CTRI/2017/09/009887) on September 22, 2017.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84553970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cognitive rehabilitation in Alzheimer’s disease","authors":"C. Voucharas, C. Tsagkaris, D. Moysidis, A. Papazoglou","doi":"10.4103/2542-3975.274080","DOIUrl":"https://doi.org/10.4103/2542-3975.274080","url":null,"abstract":"Cognitive rehabilitation has been defined as a comprehensive program aiming to cognitive enhancement. It has been developed as a method of rehabilitation for people with cognitive impairment of various etiologies such as traumatic brain injury, cerebral vascular accident, cerebral palsy, Down syndrome, Alzheimer’s disease, attention deficit hyperactivity disorder, and developmental disorders. Cognitive rehabilitation is a non-interventional, non-pharmaceutical personalized treatment. Due to the low efficacy of pharmacological approaches to the day, cognitive rehabilitation is expected to play an important role in the treatment of Alzheimer’s disease. The aim of this review is to present cognitive rehabilitation as a mental enhancement strategy in Alzheimer’s disease and to state the worth of cognitive rehabilitation in patients with Alzheimer’s disease, the benefits and drawbacks, the cost and the overall implementation, as well as the optimal future approach of the strategy.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"88 1","pages":"104 - 107"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74835757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of flash glucose-sensing technology-based continuous glucose monitoring on compliance of patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial","authors":"J. Chen, Na Luo, Li Wang, Zhenwen Zhang, Yan Liu","doi":"10.4103/2542-3975.254105","DOIUrl":"https://doi.org/10.4103/2542-3975.254105","url":null,"abstract":"Background and objectives: Multiple insulin injection therapy has been widely used in the intensive treatment of diabetes mellitus and enabled more patients to obtain good glycemic control. Intensive insulin treatment such as multiple insulin injection every day had been proven to have effects on the protection of islet and delay the onset of diabetic complications. However, during the insulin intensive therapy, severe hypoglycemia must be avoided by intensive glucose monitoring because it can increase the risks of stroke and cardiovascular disease. Conventional invasive intensive blood glucose monitoring is limited in clinical practice because it can cause patient pain and inconveniences. Patient's poor compliance in blood glucose monitoring would restrict the application of insulin intensive therapy in patients outside the hospital. The latest method of flash glucose-sensing technology-based continuous glucose monitoring (CGM) made insulin intensive therapy safer and less painful for a patient with diabetes mellitus. However, little is reported on the effects of flash glucose-sensing technology based CGM in patients receiving multiple daily injections of insulin. This study will provide evidence to validate whether flash glucose-sensing technology-based CGM can increase the behavioral self-monitoring and compliance with self-management of a Chinese patient with diabetes mellitus receiving multiple daily injections of insulin compared with conventional invasive blood glucose monitoring. Subjects and methods: This is a prospective, single-center, open-label, randomized controlled trial. Forty patients with type 2 diabetes mellitus who receive multiple daily injections of insulin at the Department of Endocrinology, Northern Jiangsu People's Hospital, Yangzhou University, China between August 2018 and December 2019 are included in this study. These patients are randomly divided to undergo conventional blood glucose monitoring (n = 20) or a flash glucose-sensing technology-based CGM group (n = 20). Patient recruitment began in August 2018 and will end in June 2019. Analysis of primary outcome measure will be completed in June 2019. The study will end in December 2019. Study protocol: 1.0. The protocol was approved by the Medical Ethics Committee of Northern Jiangsu People's Hospital (approval No. 2018045) and is performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. All participants provide written informed consent. Outcome measures: The primary outcome measure is the compliance of glycemic monitoring. The secondary outcome measures include the time taken for reaching the goal of glycemic control, HbA1c, self-management scores, the number of hypoglycemia attacks, and Hamilton Anxiety Scale score. Discussion: This study will provide evidence to validate whether flash glucose-sensing technology can increase patient's compliance of intensive insulin treatments, control blood glucose, and improve qua","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"80 6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89279489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CTDD call for papers","authors":"","doi":"10.4103/2542-3975.260961","DOIUrl":"https://doi.org/10.4103/2542-3975.260961","url":null,"abstract":"Clinical Trials in Degenerative Diseases (CTDD) has offered to publish a collection of publishing articles on clinical trials, research, pathogenesis, diagnosis, treatments, epidemiology and education for all aspects of degenerative diseases. We believe this is an excellent opportunity to present the latest works being done in this very hot and fast moving topic. We cordially invite you to contribute or recommend appropriate works (such as research articles, reviews/mini-reviews, protocols, retrospective studies, case series/reports, and editorial material) to the coming two issues in 2019. We understand that a journal’s Impact Factor is important for a variety of reasons to many in its community of authors. We encourage all readers to prioritize a journal based on their own evaluation of the work it publishes, regardless of whether it has an Impact Factor or the actual value of that metric. Authors of accepted papers will be granted complete waiver for all fees and published within 2019. Our editorial staff will assist with smooth editorial and peer review process. Instructions for Authors can be accessed at www.clinicaltdd.com/contributors.asp.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"23 1","pages":"64 - 64"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79281282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living: study protocol for a randomized, single blinded clinical trial.","authors":"C A Ciro,&nbsp;J Stoner,&nbsp;C Prodan,&nbsp;L Hershey","doi":"10.4103/2468-5658.184743","DOIUrl":"https://doi.org/10.4103/2468-5658.184743","url":null,"abstract":"<p><strong>Background: </strong>Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how we maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the STOMP (Skill-building through Task-Oriented Motor Practice) intervention which creates methods for obtaining ADL goals that support \"personhood\" and tests high-intensity protocols that appear to advantage learning and sustained learning over time. Through this study, we aim to evaluate differential outcomes by dose levels as well as assess the moderating effects of attention to task during training.</p><p><strong>Methods/design: </strong>Randomized-controlled trial with 32 participants with dementia assigned to either the original, intensive STOMP protocol (3 hours/day, 5 days/week for 2 weeks) or a less-intensive STOMP protocol (1 hour/day, 2 days/week for 2 weeks) delivered by an occupational therapy assistant in the home. ADL training is delivered using motor learning theory techniques of blocked practice, continuous verbal praise, errorless learning and intense dosing schedules. Inclusion criteria: English speaking, adults 50-80 years old that live with a legally-authorized representative that can provide consent, who can follow a one-step command, have three ADL goals they want to address and can participate in an intense therapy protocol. Exclusions include diagnoses of Creutzfeldt-Jakob Dementia, delirium or receptive/global aphasia. Recruitment will occur through direct mailing, physician referral and media/support group presentations. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Repeated measures ANOVA and graphs will be used to interpret and display results.</p><p><strong>Discussion: </strong>Through this protocol, we will examine differential outcomes by dose for the STOMP ADL intervention. Our results will inform dosing parameters for future intervention studies for people with ADRD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT02356055.</p><p><strong>Ethical approval: </strong>This study protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#4648) and will be performed in accordance with the <i>Declaration of Helsinki</i>.</p>","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"1 2","pages":"45-50"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5653308/pdf/nihms908431.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35486778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}